[한국화이자제약] WRD_WSR/ Regulatory Affairs Associate

[인사팀]

[한국화이자제약] WRD_WSR/ Regulatory Affairs Associate

Key Responsibilities

1. Assists in filing and obtaining marketing approval from the Ministry of Food and Drug Safety (MFDS) for a planned new drug (K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA).

2. Ensures quality filings of K-IND submission and its approval under supervision.

3. Updates the assigned Local Product Documents (LPDs) in consistent with the local regulations and CDS update and updates the related databases (PfLEET, GRS, local LPD drive).

4. Provides regulatory affairs related information to other divisions/departments.

5. Is aware of the external regulatory environment, including competitor intelligence and regulatory actions, in order to provide informed input to regulatory strategies.

6. Assists to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).

7. Coordinates regulatory activities between divisions/departments (Clinical Trial Support & Compliance, Business Units, Public Affairs, Quality Operations, and WSR- International & Global Product Info/HQ RA.) under supervision.

8. Assists registered products are maintained and updated in full compliance with all relevant legislation and SOPs.

9. Provides regulatory affairs related information to other divisions/departments.

10. Assists Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).

11. Assists Regulatory Affairs Manager for coordinating regulatory activities between Divisions/Business Units and timely communications with PGRD and WSR- International & Global Product Info/HQ RA.

12. Supports and collaborates with Business Units for related works.

Requirements

-     Bachelor’s degree or above(preferably Master's degree in a scientific field)

-     Pharmacist preferred

-     0~2yrs RA experience

-     Negotiating, communication and interpersonal skills

-     Working knowledge of computer applications

-     Fluency in written and spoken English

제출서류:

- 이력서(자유양식) 및 개인정보처리동의서

접수방법: https://www.linkedin.com/jobs2/view/17179695?trk=jobs_jig_jobs

- 지원사이트(위 링크) 로그인 후 화면 하단 또는 우측 상단 Apply on company website 클릭 -> 화이자 채용사이트 계정 생성 -> 필수정보 입력 -> 지원서(Resume란에 업로드)/ 개인정보 처리 동의서(‘Cover letter’란에 업로드) -> 접수 완료

- 또한, 개인정보 보호법의 요구사항에 따라, 첨부의 ‘개인정보처리 동의서’에 동의 여부를 체크하신 후 지원 시 ‘Cover letter’란에 업로드 해주시기 바랍니다. 이는 법적 요구사항으로, 본 동의서가 첨부되지 않은 지원서류는 검토 대상에서 제외됩니다.

※(https://www.linkedin.com/jobs2/view/17179695?trk=jobs_jig_jobs)을 통한 지원 이외의 이메일 및 우편접수 등은 받지 않으며, 서류전형은 합격자에 한해서만 개별 통지되는 점 양해 부탁 드립니다.

- 위 경로로 지원이 되지 않으실 경우(koreatalentacquisition@pfizer.com)으로 문의 부탁 드립니다.

 서류마감기한: 7월 15일 (화) 오후 6시

개인정보처리동의서(입사지원자용).doc